Vitamin D Supplementation in PCOS Patients (PCOvit-D)

Tanta University

Status and phase: Completed; Phase 4

Conditions: PCOS

Treatments: Drug: Vitamin D; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03898934

PCOvit-D

Details and patient eligibility

About

To assess whether Vitamin D supplementations for patients with polycystic ovary syndrome in conjunction with clomiphene citrate are beneficial or not

Full description

This study is double blinded randomized controlled study conducted at Tanta University hospitals in the period from April 2019 to March 2022. Patients and methods: One hundred twelve patients were recruited and randomly allocated into 2 groups; study group with Vitamin D supplementation and control group without Vitamin D supplementation.

Enrollment: 170 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PCOS
• Infertile
• Vitamin D deficient

Exclusion criteria

• Age less than 20 and more than 35
• Non PCOS patients
• Obese patients
• Previous ovarian surgery
• Previous oophrectomy of one ovary

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups, including a placebo group

Vitamin D group

Experimental group

Description:

These patients will receive 6000IU daily for 8 weeks then 2000IU maintenance till pregnancy or end of study

Treatment:

Drug: Vitamin D

Placebo group

Placebo Comparator group

Description:

These group will receive placebo for the same periods of study group

Treatment:

Drug: Placebo Oral Tablet